API stability in softgels
AssigneeR.P. Scherer Technologies, LLC
InventorsDouglas Keith Durham, Hitesh S. Patel
Life of this patent
Estimating the term…
Abstract
Softgels having improved stability of active pharmaceutical ingredients and methods of preparing the same are provided. In some embodiments, a softgel comprises a fill material composition and a softgel shell. In some embodiments, the fill material composition of the softgel comprises one or more active pharmaceutical ingredient (API); 2 to 15 wt. % povidone; 30 to 60 wt. % polyethylene glycol; and 0.5 to 5 wt. % propylene glycol, wherein the fill material composition has a pH of 3.75 or less. In some embodiments, the softgel shell is made from a softgel shell composition comprising an acidic component.
Claims17
A pharmaceutical softgel comprising:
- a fill material composition comprising:
- 15 to 70 wt. % of an active pharmaceutical ingredient (API), wherein the API is selected from the group consisting of ibuprofen, phenylephrine, dextromethorphan, acetaminophen, guaifenesin, and combinations thereof;
- 2 to 15 wt. % povidone;
- 0.25 to 5 wt. % potassium iodide;
- 30 to 60 wt. % polyethylene glycol;
- 0.5 to 8 wt. % hydrochloric acid;
- and
- 0.5 to 5 wt. % propylene glycol, wherein the fill material composition has a pH of 3.75 or less, and
- a softgel shell.
A fill material composition for a softgel comprising:
- 15 to 70 wt. % of an active pharmaceutical ingredient (API), wherein the API is selected from the group consisting of ibuprofen, phenylephrine, dextromethorphan, acetaminophen, guaifenesin, and combinations thereof;
- 2 to 15 wt. % povidone,
- 0.25 to 5 wt. % potassium iodide,
- 30 to 60 wt. % polyethylene glycol,
- 0.5 to 8 wt. % hydrochloric acid;
- and
- 0.5 to 5 wt. % propylene glycol,
- wherein the fill material composition has a pH of 3.75 or less.
A method of preparing a softgel comprising:
- combining 30 to 60 wt. % polyethylene glycol, 0.5 to 5 wt. % propylene glycol, 2 to 15 wt. % povidone, 0.25 to 5 wt. % potassium iodide, 15 to 70 wt. % of an active pharmaceutical ingredient (API), and 0.5 to 8 wt. % an acidic component comprising citric acid, formic acid, acetic acid, and/or hydrochloric acid to form a fill material comprising a pH of 3.75 or less, wherein the API is selected from the group consisting of ibuprofen, phenylephrine, dextromethorphan, acetaminophen, guaifenesin, and combinations thereof;
- and
- encapsulating the fill material in a softgel shell to form a softgel.
Dependencies are inferred from the claim text.